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OpenTrials
Completed

NCT Number: NCT02236897

PET Imaging in ALS Patients

This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and monitoring progression of ALS, based on a well established basic science pathway, published human autopsy data, preliminary data in ALS mutant mice, and our recently published data using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy human volunteers.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ALS patients, ranging in age from 18-80.
  • Must meet El Escorial Criteria for Probable or Definite ALS.
  • Disease duration >1 year, but <3 years.
  • Weakness in at least two extremities.
  • Forced vital capacity less than 80% and greater than 50%.

Exclusion criteria

  • Documented orthopnea or otherwise unable to lie flat in a PET scanner for 90 minutes.
  • Presence of pacemakers, aneurysm clips, shrapnel, or other implanted metallic devices that would preclude an MRI scan.
  • Absence of sufficient collateral arterial circulation for radial arterial line placement in both wrists.
  • Significant abnormalities of hepatic or renal function, or illicit substance use.
  • Positive drug screen. (Subjects currently taking prescribed narcotic medication who have a positive drug screen for this medication will not be excluded. Medication history will be obtained during screening).
  • Weighs > 350 lbs.

Treatment and study plan

PET Scanning

Other

Primary outcomes

  1. Glutamate Receptor Distribution

    Time frame: 1 year

    The two primary outcome variables (VT and BPND) are quantitative estimates of mGluR5 distribution in the defined central nervous system regions. We will employ plasma reference graphical analysis (PRGA) which yielded the most accurate estimates of BPND and VT in a test-retest scheme. We will perform various analyses to determine if BPND or VT measurements in the volumes of interest differ between the ALS and control subject groups.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • ALS Association

Registry information

Official study title

Metabotropic Glutamate Receptor 5 (mGluR5) Imaging in Amyotrophic Lateral Sclerosis (ALS) Patients and Healthy Volunteers

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2014
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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